Cosmetics play a significant role in our daily lives, enhancing our beauty and self-esteem. In India, the cosmetics industry has witnessed exponential growth in recent years, with consumers demanding a wide range of products. However, ensuring the safety and quality of these products is of paramount importance.
The cosmetics regulation in India falls under the purview of the Drugs and Cosmetics Act, 1940 and the Cosmetic Rules 2020. The primary regulatory authority responsible for overseeing the cosmetics industry is the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. All cosmetics that are manufactured or imported into India must be registered with the CDSCO.
Definition of cosmetics as per Indian regulations
The definition of cosmetics as per Indian Regulations are specified in per Section 3(aaa) of the Drugs and Cosmetics Act, 1940, Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic.
Cosmetics regulation in India
The CDSCO's objectives are to ensure the safety, quality, and efficacy of cosmetics, and to protect consumers from misleading and deceptive claims. The CDSCO is responsible for enforcement of cosmetics regulation in India; manufacturing, cosmetic import license India and registration of cosmetics; inspection of cosmetic manufacturing facilities and importers and labeling of cosmetics.
The CDSCO has set a number of standards and guidelines for cosmetics in India. These standards and guidelines cover a wide range of aspects of cosmetics, including their composition, safety, and performance. The CDSCO has also issued a number of guidelines for cosmetics.
Regulatory Requirements for cosmetics in India
The following are some of the key regulatory requirements for cosmetics in India:
Manufacturing License: All manufacturers of cosmetics in India must obtain a manufacturing license from the State Drug Control Department.
Import License: All importers of cosmetics in India must obtain an import license for cosmetics in India from the CDSCO.
Labeling: All cosmetics must be labeled in accordance with the Drugs and Cosmetics Rules, 1945.
Good Manufacturing Practices (GMP): All manufacturers of cosmetics in India must comply with the GMP regulations set by the CDSCO.
The CDSCO and the State Drug Control Departments regularly inspect cosmetic manufacturing facilities and products to ensure that they are complying with the regulatory requirements. Any product that is found to be non-compliant with the requirements may be subject to regulatory action.
Here are some additional regulatory requirements for cosmetics in India:
Prohibition on the use of certain ingredients: Certain ingredients are prohibited from being used in cosmetics in India. These include ingredients such as hexachlorophene, lead compounds, and arsenic compounds.
Regulation of the import and manufacture of cosmetics containing mercury: The import and manufacture of cosmetics containing mercury is regulated in India. Cosmetic products that contain mercury must be approved by the DCGI before they can be imported or manufactured.
Prohibition of the import of cosmetics tested on animals: The import of cosmetics that have been tested on animals is prohibited in India.
Standards for cosmetics in India
The standards for cosmetics in India are set by the Bureau of Indian Standards (BIS). The BIS is a statutory body under the Ministry of Consumer Affairs, Food & Public Distribution, Government of India. The BIS is responsible for the development and promotion of standards in India.
The BIS has published a number of standards, specific to each category of cosmetics. Few of the standards are listed below and the manufacturers shall refer to the standards applicable for their cosmetic product.
IS 4755:2013 - Cosmetics: Specification for Toothpaste
IS 4756:2013 - Cosmetics: Specification for Face Powder
IS 4757:2013 - Cosmetics: Specification for Talcum Powder
IS 4758:2013 - Cosmetics: Specification for Creams and Lotions
IS 4759:2013 - Cosmetics: Specification for Shampoos and Conditioners
IS 4760:2013 - Cosmetics: Specification for Soaps and Detergents
These standards cover a wide range of aspects of cosmetics, including their composition, safety, and performance.
Registration of cosmetics in India -
The DCGI also operates a system for the cosmetic registration India. All cosmetics that are manufactured or imported into India must be registered with the DCGI.
Import License :
Either the Authorized Agent or Authorized subsidiary of the foreign manufacturer or any importer in India can apply in Form COS-1 for import Registration Certificate for import of cosmetic products in India and obtain the certificate in Form COS-2.
Process for cosmetic product registration in India
The first step would be to determine if the products is meets the definition of cosmetics as per Indian regulations. The following are the steps for cosmetic registration in India:
Create an account on the CDSCO Sugam portal.
Fill out the online application form for cosmetic product registration.
Upload the required documents, including:
A copy of the Certificate of Incorporation of the company.
A copy of the Memorandum of Association and Articles of Association of the company.
A copy of the free sale certificate issued by the competent authority of the country of origin of the cosmetics (if applicable).
A copy of the Certificate of Analysis (CoA) of the cosmetics issued by a recognized laboratory.
A copy of the label of the cosmetics.
A sample of the cosmetics.
Pay the applicable registration fee.
Submit the application form and supporting documents.
Once the DCGI has approved the registration of a cosmetic, it will be issued with a registration number. The registration number must be displayed on the label of the cosmetic. The DCGI also conducts regular inspections of cosmetic manufacturing facilities to ensure that they are complying with the relevant standards and guidelines.
CDSCO Cosmetic Registration Fee :
The applicant would have to pay fees for the CDSCO cosmetic registration as specified in Third Schedule of Indian Cosmetic Rules, 2020.
Different colour/shade or flavour of a product can be considered as a variant for the purpose of registration for import of cosmetics into the country.
Indian regulatory requirements for labeling of cosmetics
The cosmetic labeling requirements India are governed by the Cosmetics Rules 2020 and the Legal Metrology (Packaged Commodities) Rules, 2011. The following information must be clearly and prominently displayed on the label of all cosmetics sold in India:
Name of the cosmetic Product
Name and address of the manufacturer or importer
Net quantity in terms of a standard unit of weights and measures
Date of manufacture or packing or import
Expiry date (if any)
List of ingredients in descending order of concentration
Any warning or caution statements
In addition to the above information, the following information must be displayed on the label of imported cosmetics:
Name and address of the importer
Country of origin
Generic name of the commodity packed
The cosmetic labeling requirements in India are also subject to the Legal Metrology (Packaged Commodities) Rules, 2011. These rules require that the following information be displayed on the label of all packaged commodities, including cosmetics:
Generic name of the product
Maximum retail price
Contact details for customer care
Date of import, if applicable
The label must be written in English and Hindi, and must be easy to read. The font size must not be less than 1mm.
The following information must be displayed on the inner label of cosmetics:
Adequate directions for use
Any warning, caution or special directions
Names and quantities of ingredients that are hazardous or poisonous
The inner label must be written in English and Hindi, and must be easy to read. The font size must not be less than 0.5mm.
The label of a cosmetic must be clear, legible, and in English. The label must also be prominently displayed on the cosmetic container. The DCGI may also require additional information to be displayed on the label of a cosmetic, depending on the nature of the cosmetic. Failure to comply with the cosmetic labeling requirements in India may result in penalties, including fines and imprisonment.
The regulation of cosmetics in India is vital for safeguarding the health and well-being of consumers. The government has taken steps to improve the regulatory framework, but challenges persist. It is essential for all stakeholders, including manufacturers, regulatory authorities, and consumers, to work together to ensure the continued safety and quality of cosmetics in the Indian market. As the industry continues to grow, a more robust regulatory framework will be crucial for its sustainable development.